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Data / Medical devices / Suit, Surgical / Vietnam

FDA-registered makers of Suit, Surgical in Vietnam: 8 establishments

8 establishments in Vietnam are registered with the FDA to make Suit, Surgical (product code FXO). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

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Device
Suit, Surgical
Product code
FXO
Country
Vietnam

Makers of Suit, Surgical in Vietnam

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
An Lanh Investment And Trading Company LimitedThanh Nam Ward Ninh Binh, VietnamExporter to the US, Manufacturer0000api.fda.gov
Environstar Group Company LimitedHung Yen Province, VietnamContract manufacturer0000api.fda.gov
GLX Medical Devices Company LimitedBien Hoa Dong Nai, VietnamContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Hanh Minh Manufacturing Trading Company LimitedBien Hoa Dong Nai, VietnamManufacturer, Repackager or relabeler0000api.fda.gov
Quang Nam Medical Devices Factory Branch Of Danameco Medical Joint Stock CorporationDien Ban Bac Ward Da Nang, VietnamContract manufacturer, Manufacturer0000api.fda.gov
Sanmu (vietnam) Protective Products Co., LtdDuc Hoa Commune Tay Ninh, VietnamExporter to the US, Manufacturer0000api.fda.gov
Stevimed Medical Joint Stock CompanyCan Giuoc Commune Tay Ninh, VietnamManufacturer0000api.fda.gov
Vien Phat Import Export Service Trading Joint Stock CompanyBen Thanh Ward Ho Chi Minh, VietnamManufacturer0000api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.